Oncology Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 May 2023

On the 26th of May 2023, CHMP released its meeting highlights for the month of May. The main discussion points of the meeting are as follows: 

Recommendations on extensions of therapeutic indication 

Opdivo (nivolumab)  

• Indication: Used to treat adults with melanoma, NSCLC, advanced renal cell carcinoma, classical Hodgkin lymphoma, urothelial cancer, malignant pleural mesothelioma etc.
• The committee recommended Opdivo for extension of indication, which now includes Opdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1%. 

Following a CHMP opinion the European Commission usually takes a legally binding authorisation after 67 days or 35 days with an accelerated assessment. 

Notification Link: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 May 2023 

Document Source: Opdivo